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The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasmafit® Revision Structan® | Plasmafit® Revision Structan® Hip Endoprosthesis Cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmafit® Revision Structan® | Device | Plasmafit® Revision Structan® Hip Endoprosthesis Cup |
|
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (Functional results of the operated hip) over time | The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time | up to five years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the implant | Any removal or exchange of the acetabular cup or the polyethylene inlay is defined as revision. A removal of the stem is not evaluated as acetabular revision but will be documented and evaluated as part of postoperative complications. The revision-free survival will be assessed using the Kaplan-Meier method. | up to five years postoperatively |
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Inclusion Criteria
Exclusion Criteria
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Patients having acute disorders of the hip, requiring primary or revision surgery, which cannot be treated by other therapies:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Landgraeber, Prof. Dr. | University Hospital, Saarland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädische Klinik König-Ludwig-Haus | Würzburg | Bavaria | 97074 | Germany | ||
| Herzogin Elisabeth Hospital |
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| Quality of Life over time | EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems/some or moderate problems/extreme problems). | up to five years postoperatively |
| Radiological Assessment: Osseointegration of the cup over time | The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for osteolysis the implant, to allow an estimation of the osseous integration and stability of the implant. | at 3 months, 24 months, 5 years follow-up |
| Radiological assessment: Radiographic loosening of the cup over time | The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for and radiolucent lines around the implant, to allow an estimation of the osseous integration and stability of the implant. | at 3 months, 24 months, 5 years follow-up |
| Technical problems during surgery | Technical problems with instruments, implants or containers, instrument related issues | Intraoperative |
| Impingement | The incidence of impingement during intraoperative mobilization is documented; | Intraoperative |
| General handling of instruments / containers | Complaints or problems with the handling of instruments, implants or containers, instrument related issues | Intraoperative |
| Complications | All complications in the postoperative course are recorded | up to 5 years postoperatively |
| Braunschweig |
| Niedersachse |
| 38124 |
| Germany |
| Gemeinschaftskrankenhaus Bonn | Bonn | North Rhine-Westphalia | 53113 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Saarland | 66421 | Germany |
| ID | Term |
|---|---|
| D010014 | Osteolysis |
| D007592 | Joint Diseases |
| D012213 | Rheumatic Fever |
| D006620 | Hip Fractures |
| D005271 | Femur Head Necrosis |
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010020 | Osteonecrosis |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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